Governance and Ethics

The health research that the BioResource supports can only proceed because of your participation, the information and the samples you give, and most importantly your trust in out ability to protect your interest. The Governance and Ethics team covers all those aspects, by ensuring we have the right paperwork and processes in place, and that our staff is appropriately trained. Governance refers to how the NIHR BioResource is regulated and held accountable. Ethics refers to protecting the rights, safety, dignity and well-being of research participants and ensuring that research has potential benefit to participants, science and society. 

Governance 

Put simply, our slogan is:  

Say what we do; do what we say. 

In practice, this means writing lots of policies and procedures to describe what we do, and then have independent bodies check that this is what we actually do. 

We also perform internal monitoring and audits to verify our processes and to ensure teams follow the guidance. 

Ethics

The BioResource invites adults and children (from birth onwards) with common or rare diseases, as well as people from the general population, to take part in research studies, or to contribute to the research tissue bank. Participants provide health and care information, and a biological sample (blood or saliva). 

All these activities are described in protocols that have been reviewed and given a favourable opinion by an independent Research Ethics Committees (RECs). RECs review research applications and all participant materials (posters, adverts, information leaflets) and give their opinion on whether the research is ethical. RECs are part of a framework that regulates health and care research, under the NHS Health Research Authority (HRA). 
The HRA quite rightly expects us to treat all the samples and data we are given by our participants with the appropriate care and attention.  

The NIHR BioResource is compliant with the NHS Data Security and Protection Toolkit , which is used to assess organisations handling NHS patient data to ensure the right processes are in place. 

How we do this is described in these documents: 

It is important to us that our documentation is accessible and of a high standard. We work with local and national patient and public advisory groups to try to achieve this.  

The NIHR BioResource has ethical favourable opinion for the NIHR BioResource – Research Tissue Bank (22/EE/0230) which also covers the following programmes: 

  • DNA, Children + Young People’s Health Resource (D-CYPHR) 
  • Improving Black Health Outcomes (IBHO)  
  • COVID-19 BioResource (long-COVID)

Our dormant cohorts -that no longer invite new participants- include: 

  • Covid-19 Clinical NeuroScience Study (COVID-CNS)

The BioResource also has a number of nationally approved programmes, which have all had separate REC favourable opinion and/or Health Research Authority approval: 

Patient Information Sheet and Consent Form 

Here is an example of a Patient Information Sheet and a Consent Form.  Each group and study can be slightly different to capture specialist study needs.  

The core requirements across the NIHR BioResource are that participants consent to: 

  • donate a blood sample (or saliva in some cases)
  • DNA sequencing and analysis of their donated sample(s)
  • the NIHR BioResource accessing their medical, health, social care and educational records  
  • be recallable for future studies (consent decision made on each individual study with no obligation to take part)

On the financial side, we receive funding from the tax-payer – we have a grant from the National Institute for Health and Care Research (NIHR) which ultimately comes from the UK Government Department of Health & Social Care. Our spending is reviewed by both the NIHR and an independent Oversight Board to make sure we stay on track.